Protocol summary
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Study aim
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Determining the effect of comprehensive tele-empowerment program on self-care behaviors, uncertainty and readmission of heart failure patients
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Design
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Randomized clinical trial; with control group, parallel groups, without blindness
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Settings and conduct
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Selecting 96 patients with heart failure referred to Imam Khomeini Hospital in Tehran and dividing them into two groups of control and intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Diagnosis of class II or III heart failure according to the New York Heart Association classification; Diagnosis of heart failure for at least 3 months; Ability to read and write; Access and ability to use smartphones and the Internet; Willingness to participate and complete intervention. Exclusion criteria: Mental and cognitive disorders; Having vision, hearing or speaking deficits; Participation in similar programs; Heart failure exacerbation; Experience of severe psychological distress.
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Intervention groups
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The control group receives usual care. the intervention group will receive 10 weeks of intervention including 6 weeks of comprehensive tele-empowerment program and 4 weeks of follow-up. Empowerment program will be implemented weekly through the Internet (online and offline) with the following topics: Familiarity with heart failure, clinical manifestations monitoring, diet modification, physical activity improvement, drug management, stress management, spiritual self-awareness and offering religious coping strategies. Simultaneously, patients will join virtual groups on the electronic messaging app and 5 stages of the empowerment program, including 1) needs assessment 2) goal setting 3) structured education 4) self-care plan development 5) evaluation will be repeated each week. Finally, patients will be followed up by telephone and their questions will be answered.
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Main outcome variables
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Self-care behaviors and uncertainty
General information
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Reason for update
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The sampling time was updated.
Because of more cooperation, the recruitment center was changed to Imam Khomeini Hospital in Tehran.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100725004443N30
Registration date:
2022-02-25, 1400/12/06
Registration timing:
prospective
Last update:
2023-07-13, 1402/04/22
Update count:
3
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Registration date
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2022-02-25, 1400/12/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-02-19, 1401/11/30
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Expected recruitment end date
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2023-07-30, 1402/05/08
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of comprehensive tele-empowerment program on self-care behaviours, uncertainty and readmission in patients with heart failure
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Public title
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The effect of comprehensive tele-empowerment program on self-care, uncertainty and readmission in patients with heart failure
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Medical diagnosis of class II or III heart failure (according to the New York Heart Association [NYHA] classification) based on the patient's medical record
Medical diagnosis of heart failure for at least 3 months
Ability to read and write Persian language
Access and ability to use smart phones and the Internet
Willingness to participate and complete intervention sessions, social media group interactions, and data collection measures
Exclusion criteria:
Diagnosed mental and cognitive disorders documented in the medical record
Having vision, hearing, or speaking deficits
Participation in or experience of joining similar empowerment programs
Heart failure exacerbation
reporting experience of severe psychological distress during the study period.
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
96
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The samples will be selected by continuous sampling and the patients will be placed in two groups of control and case by Block Balanced Randomization (BBR). By using the free website http://www.randomization.com/, the assignment sequence will take place. In such a way that the number of subjects in each block will be set to 4, for the control group letter A and for the case group, the letter B will be considered, and finally, by approving the Randomization Sequence in the system for 24 blocks, The assignment sequence will be created for the 96 samples by combining the letters A and B. Finally, the cards containing the blocks will be placed inside the standard envelope, and as a result, allocation concealment will be considered and observed. Based on qualified samples, a Shuffling Envelope will be taken by the researcher accidentally. Finally, the random allocation method will be determined by the research samples.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-02-09, 1400/11/20
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Ethics committee reference number
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IR.TUMS.FNM.REC.1400.194
Health conditions studied
1
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Description of health condition studied
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Patients with heart failure
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ICD-10 code
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I50
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ICD-10 code description
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Heart failure
Primary outcomes
1
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Description
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Self-care behaviors
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Timepoint
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Before the intervention, immediately after ending the intervention
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Method of measurement
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Nine-Item European Heart Failure Self-Care Behavior Scale (EHFScBS-9)
2
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Description
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uncertainty
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Timepoint
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Before the intervention, immediately after ending the intervention
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Method of measurement
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Mishel Uncertainty in Illness Scale - Community form (MUIS-C)
Secondary outcomes
1
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Description
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Number and duration of emergency hospital readmission of patients
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Timepoint
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Immediately after ending the intervention
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Method of measurement
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Self-Report of Patients
Intervention groups
1
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Description
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Control group: These patients do not receive any intervention from the researcher, and after the initial visit by the physician, patients will be provided with routine care in heart failure.
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Category
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Behavior
2
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Description
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Intervention group: Patients in the intervention group will receive 10 weeks of intervention, including 6 weeks of comprehensive tele-empowerment program and 4 weeks of follow-up. Initially, patients will join virtual groups of 10 to 15 people, and the empowerment program will be done comprehensively and according to the physical, psychological and spiritual needs of patients; through the Internet and on the electronic massaging platform. Each week, a specific topic will be addressed to promote patients' self-care. Topics will include familiarity with heart failure and clinical manifestations monitoring, diet modification, physical activity improvement, drug management, stress management and relaxation techniques, spiritual self-awareness and religious coping strategies. The content of each session will be available to all patients equally for 6 weeks as a combination of online and offline sessions (3 online sessions and 3 offline sessions).In offline sessions, an e-booklet and/or an instructional video will be sent to virtual groups, and in online sessions, a Skyroom link will be placed in the virtual group to hold online group sessions. Online group meetings with members of groups of 10 to 15 people formed on the social network will be held for 45 to 60 minutes via the Skyroom platform. This empowerment program will include 5 steps entitled 1) Needs Assessment 2) Goal Setting 3) Structured Education 4) Self-Care Plan Development 5) Evaluation which all steps will be repeated by the researcher and through the electronic messaging program for all the mentioned sessions for each week. Finally, over the next four weeks, patients will be followed up by a 10-minute phone call and their questions will be answered.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The collected deidentified IPD including demographic information, medical history, study outcomes, and other relevant variables
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When the data will become available and for how long
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Data will be available 6 months after publication of the study results up to a period of 5 years after the end of the study.
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To whom data/document is available
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The deidentified IPD and supporting information will be made available to qualified researchers upon reasonable request.
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Under which criteria data/document could be used
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Access to the data will be granted to qualified researchers and for research purposes only. Researchers must be affiliated with an academic or research institution and provide the approved proposal and evidence of their qualifications, such as a curriculum vitae or publication record. Requests will be reviewed by the corresponding author to ensure that they are consistent with the study's original aims and objectives.
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From where data/document is obtainable
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To obtain the deidentified IPD, interested researchers should submit a request to the corresponding author by email.
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What processes are involved for a request to access data/document
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To request access to the deidentified IPD, interested researchers should submit a request to the corresponding author including a detailed research plan that outlines the research question(s) being addressed, the specific data being requested, and the analytic methods to be used. Researchers should also provide the approved proposal and also evidence of their qualifications and data protection plans.
Requests will be reviewed by the corresponding author to ensure that they are consistent with the study's original aims and objectives. Upon receipt of a request, the corresponding author will review the request and respond within 10 business days.
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Comments
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